カナダ - 英語 - Health Canada

emd serono, a division of emd inc., canada - interferon beta-1a - solution - 66mcg - interferon beta-1a 66mcg - immunomodulatory agents

カナダ - 英語 - Health Canada

emd serono, a division of emd inc., canada - interferon beta-1a - solution - 132mcg - interferon beta-1a 132mcg - immunomodulatory agents

カナダ - 英語 - Health Canada

emd serono, a division of emd inc., canada - interferon beta-1a - solution - 132mcg - interferon beta-1a 132mcg - immunomodulatory agents

カナダ - 英語 - Health Canada

biogen canada inc - interferon beta-1a; water - powder for solution - 30mcg; 1.1ml - interferon beta-1a 30mcg; water 1.1ml - immunomodulatory agents

カナダ - 英語 - Health Canada

biogen canada inc - interferon beta-1a - powder for solution - 60mcg - interferon beta-1a 60mcg - immunomodulatory agents

カナダ - 英語 - Health Canada

biogen canada inc - interferon beta-1a - solution - 30mcg - interferon beta-1a 30mcg - immunomodulatory agents

アメリカ合衆国 - 英語 - NLM (National Library of Medicine)

csl behring llc - antihemophilic factor, human recombinant (unii: p89dr4ny54) (antihemophilic factor, human recombinant - unii:p89dr4ny54) - antihemophilic factor, human recombinant 250 [iu] in 2.5 ml - helixate® fs is a recombinant antihemophilic factor indicated for: helixate fs is not indicated for the treatment of von willebrand disease. helixate fs is contraindicated in patients who have life-threatening hypersensitivity reactions, including anaphylaxis to mouse or hamster protein or other constituents of the product (sucrose, glycine, histidine, sodium, calcium chloride, polysorbate 80, imidazole, tri-n-butyl phosphate, and copper). pregnancy category c animal reproduction studies have not been conducted with helixate fs. it is also not known whether helixate fs can cause fetal harm when administered to a pregnant woman or affect reproductive capacity. helixate fs should be given to a pregnant woman only if clearly needed. there is no information available on the effect of factor viii replacement therapy on labor and delivery. helixate fs should be used only if clinically needed. it is not known whether this drug is excreted into human milk. because many drugs are excreted into human milk, caution sho

アメリカ合衆国 - 英語 - NLM (National Library of Medicine)

bayer healthcare llc - antihemophilic factor, human recombinant (unii: p89dr4ny54) (antihemophilic factor, human recombinant - unii:p89dr4ny54) - antihemophilic factor, human recombinant 1000 [iu] in 2.5 ml - kogenate® fs is a recombinant antihemophilic factor indicated for: kogenate fs is not indicated for the treatment of von willebrand disease. kogenate fs is contraindicated in patients who have life-threatening hypersensitivity reactions, including anaphylaxis to mouse or hamster protein or other constituents of the product (sucrose, glycine, histidine, sodium, calcium chloride, polysorbate 80, imidazole, tri-n-butyl phosphate, and copper). there are no data with kogenate fs use in pregnant women to inform on drug-associated risk. animal reproduction studies have not been conducted with kogenate fs. it is also not known whether kogenate fs can cause fetal harm when administered to a pregnant woman or affect reproductive capacity. in the u.s. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2-4% and 15-20%, respectively. there is no information regarding the presence of kogenate fs in human milk, the effects on the breastfed infant, or the effects on milk production. the developmental and health benefits of breastfeeding should be considered along with the mother’s clinical need for kogenate fs and any potential adverse effects on the breastfed child from kogenate fs or from the underlying maternal condition. safety and efficacy studies have been performed in previously untreated and minimally treated pediatric patients. children, in comparison to adults, present higher factor viii clearance values and, thus, lower half-life and recovery of factor viii. this may be due to differences in body composition.13 account for this difference in clearance when dosing or following factor viii levels in the pediatric population [see clinical pharmacology (12.3)] . routine prophylactic treatment in children ages 0–2.5 years with no pre-existing joint damage has been shown to reduce spontaneous joint bleeding and the risk of joint damage. this data can be extrapolated to ages >2.5–16 years for children who have no existing joint damage [see clinical studies (14)] . clinical studies with kogenate fs did not include patients aged 65 and over. dose selection for an elderly patient should be individualized.

アメリカ合衆国 - 英語 - NLM (National Library of Medicine)

takeda pharmaceuticals america, inc. - antihemophilic factor, human recombinant (unii: p89dr4ny54) (antihemophilic factor, human recombinant - unii:p89dr4ny54) - antihemophilic factor, human recombinant 125 [iu] in 1 ml - advate [antihemophilic factor (recombinant)] is a recombinant antihemophilic factor indicated for use in children and adults with hemophilia a (congenital factor viii deficiency) for: - control and prevention of bleeding episodes. - perioperative management. - routine prophylaxis to prevent or reduce the frequency of bleeding episodes. advate is not indicated for the treatment of von willebrand disease. advate is contraindicated in patients who have life-threatening hypersensitivity reactions, including anaphylaxis, to mouse or hamster protein or other constituents of the product (mannitol, trehalose, sodium chloride, histidine, tris, calcium chloride, polysorbate 80, and/or glutathione). risk summary there are no data with advate use in pregnant women to inform a drug-associated risk. animal reproduction studies have not been conducted with advate. it is not known whether advate can cause fetal harm when administered to a pregnant woman or whether it can affect reproductive capacity. in the u.s. general popu

アメリカ合衆国 - 英語 - NLM (National Library of Medicine)

baxalta us inc. - antihemophilic factor, human recombinant (unii: p89dr4ny54) (antihemophilic factor, human recombinant - unii:p89dr4ny54) - antihemophilic factor, human recombinant 250 [iu] in 5 ml - adynovate, antihemophilic factor (recombinant), pegylated, is a human antihemophilic factor indicated in children and adults with hemophilia a (congenital factor viii deficiency) for: - on-demand treatment and control of bleeding episodes - perioperative management - routine prophylaxis to reduce the frequency of bleeding episodes limitation of use adynovate is not indicated for the treatment of von willebrand disease. adynovate is contraindicated in patients who have had prior anaphylactic reaction to adynovate, to the parent molecule (advate), mouse or hamster protein, or excipients of adynovate (e.g. tris, mannitol, trehalose, glutathione, and/or polysorbate 80). risk summary there are no data with adynovate use in pregnant women to inform a drug-associated risk. animal reproduction studies have not been conducted with adynovate. it is unknown whether adynovate can cause fetal harm when administered to a pregnant woman or can affect reproduction capacity. adynovate should be given to a pregnant woman only